NCT07135986

Immunogenicity and Safety Study of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents in China

A Phase 3, Modified Double-blind, Multi-center Study of the Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered in Healthy Children and Adolescents (2 to 17 Years of Age) in China

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,602 (estimated)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 3, modified double-blind, randomized, parallel-group, active-controlled, multicenter study with 2 arms and 4 groups to evaluate the immunogenicity and safety of MenACYW conjugate vaccine in children and adolescents versus control meningococcal vaccines licensed in China. Study details include: * The study duration will be approximately 180 days. * The vaccination visit will be Visit 1. * The visit frequency will be 2 on-site visits with a 30-day interval. A safety visit/telephone call is planned on the ninth day after the vaccination for all groups; a safety follow-up telephone call is planned for all groups 180 days post the last vaccination.

Detailed description

The duration of each participant's participation will be approximately 180 days.

Conditions

• Meningococcal Infection
• Healthy Volunteers

Interventions

Type	Name	Description
BIOLOGICAL	MenACYW conjugate vaccine	Pharmaceutical form:Liquid solution-Route of administration:Intramuscular (IM) injection
BIOLOGICAL	MenACYW135 polysaccharide vaccine	Pharmaceutical form: Lyophilized powder-Route of administration:IM injection
BIOLOGICAL	MenAC conjugate vaccine	Pharmaceutical form:Lyophilized powder-Route of administration:IM injection

Timeline

• Start date: 2025-09-26
• Primary completion: 2026-04-27
• Completion: 2026-09-23
• First posted: 2025-08-22
• Last updated: 2026-04-17

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated drug study